Cohort Study of Blood Biomarkers for TES

Overview

In this study, high-throughput screening and multi-omics (transcriptomics and proteomics) joint analysis technology will be employed to explore potential CTE/TES biomarkers (RNA and protein) in blood and its exosomes. Thereafter, these biomarkers will be combined with the reported TBI biomarkers to create a novel set of CTE/TES molecular diagnostic signatures. The findings may open a new avenue for the clinical diagnosis of the disease and the future research on its therapeutic strategy.

Full Title of Study: “Observational Cohort Study of Blood Transcriptomics and Proteomics Information as Biomarkers of Traumatic Encephalopathy Syndrome”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: December 1, 2023

Interventions

  • Diagnostic Test: Blood tests, Cognitive function tests, head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination
    • Blood tests (30-ml venous blood) for the following items. 1) Transcriptomics and proteomics high-throughput detection and quantitative verification; 2) Exosomal transcriptomics and proteomics high-throughput detection and quantitative verification; 3) Quantitative detection for classical biomarkers of traumatic brain injury, including S100B, GFAP, UCH-L1, NFL, T-Tau and p-Tau181. Cognitive function tests, including RPQ, MMSE and MoCA. Possible head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination

Arms, Groups and Cohorts

  • Athletes with rmTBI history
    • 50 active or retired athletes from the Weightlifting, Wrestling, Judo, Boxing and Taekwondo Sports Management Center of Tianjin Sports Bureau
  • Patients with rmTBI history
    • 50 patients with multiple (≥2 times) exposure to brain trauma attending Tianjin Medical Insurance designated hospitals such as Tianjin Medical University General Hospital
  • Healthy volunteer
    • 20 healthy volunteers

Clinical Trial Outcome Measures

Primary Measures

  • Blood level of novel protein biomarkers for CTE/TES
    • Time Frame: Baseline
    • Novel protein biomarkers for CTE/TES will be screened out by transcriptomics + proteomics high-throughput detection and multi-omics bioinformatics analysis. Their levels will be further verified using ELISA assay.
  • Blood level of novel RNA biomarkers for CTE/TES
    • Time Frame: Baseline
    • Novel RNA biomarkers for CTE/TES will be screened out by transcriptomics + proteomics high-throughput detection and multi-omics bioinformatics analysis. Their levels will be further verified using RT-PCR.

Secondary Measures

  • Blood level of classical biomarkers for CTE/TES
    • Time Frame: Baseline
    • Blood S100B, GFAP, UCH-L1, NFL, T-Tau and p-Tau181 level detected by ELISA assay

Participating in This Clinical Trial

Inclusion Criteria

1. Athletes and patients with traumatic brain injury

  • Age ≥ 18 and ≤ 80 years old with independent behavior ability or authorized legal representative. – Have a clear history of repetitive mild TBI, concussion or subconcussion. – The most recent head injury occurred 3 months ago. 2. Healthy Volunteers – Age ≥ 18 and ≤ 80 years old with independent behavior ability. – No history of repetitive mild TBI, concussion or subconcussion. – Fully understands the nature of the study, and voluntarily participates and signs the informed consent. Exclusion Criteria:

1. Athletes and patients with traumatic brain injury

  • Pregnant or lactating women. – History of other neurological diseases. – History of tumors, hematological diseases, severe cardiopulmonary diseases, hepatic failure or renal failure. – Have participated in clinical trials in the past four weeks. – The investigator believes that not appropriate for inclusion. 2. Healthy Volunteers – Pregnant or lactating women. – History of TBI or other neurological diseases. – History of tumors, hematological diseases, severe cardiopulmonary diseases, hepatic failure or renal failure. – Have participated in clinical trials in the past four weeks. – The investigator believe that not appropriate for inclusion.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Tianjin Medical University
  • Collaborator
    • Tianjin Medical University General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xintong Ge, Principal Investigator – Tianjin Medical University General Hospital
  • Overall Official(s)
    • Ping Lei, Doctor, Principal Investigator, Tianjin Medical University
  • Overall Contact(s)
    • Xintong Ge, Doctor, 86-022-60364359, xge@tmu.edu.cn

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